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Drug Information

Product NDC: 51672-4048

Proprietary Name: Clotrimazole and Betamethasone Dipropionate

Non Proprietary Name: Clotrimazole and Betamethasone Dipropionate

Active Ingredient(s):
  • 10 mg/g CLOTRIMAZOLE

Administration Route(s): TOPICAL

Dosage Form(s): CREAM

Pharmacy Class(es):
  • Azole Antifungal [EPC];
  • Azoles [CS];
  • Corticosteroid Hormone Receptor Agonists [MoA];
  • Corticosteroid [EPC]

Labeler Information

Labeler Name: Taro Pharmaceuticals U.S.A., Inc.
FDA Application Number: ANDA075673
Marketing Category: ANDA
Start Marketing Date:5/29/2001

Package Information

No. Package Code Package Description Billing Unit
151672-4048-11 TUBE in 1 CARTON (51672-4048-1) / 15 g in 1 TUBEGM
251672-4048-61 TUBE in 1 CARTON (51672-4048-6) / 45 g in 1 TUBEGM

NDC Record

Field Name Field Value Definition
PRODUCT NDC51672-4048The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEClotrimazole and Betamethasone DipropionateThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEClotrimazole and Betamethasone DipropionateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECREAMThe translation of the dosage form Code submitted by the firm.
ROUTE NAMETOPICALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE5/29/2001This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at under Structured Product Labeling Resources.
APPLICATION NUMBERANDA075673This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMETaro Pharmaceuticals U.S.A., Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEBETAMETHASONE DIPROPIONATE; CLOTRIMAZOLEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
PHARM CLASSESAzole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] 

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This page was last updated on: 2/1/2023